21 CFR 880.6860 — Sterilizer, Ethylene-Oxide Gas

General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6860

Identification

An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
FLFSterilizer, Ethylene-Oxide Gas226
MLRSterilizer, Chemical2473rd Party
PJJTwo Or More Sterilant Sterilizer26
Innolitics

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